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Transgene seeks new taker for TG4010 as Novartis opts out

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By Cormac Sheridan
Staff Writer

Shares in Transgene SA dropped 15 percent Tuesday as Novartis AG decided not to trigger an option on its therapeutic vaccine TG4010, which is currently undergoing a phase IIb/III trial in non-small-cell lung cancer (NSCLC).

Strasbourg, France-based Transgene can be plausibly considered the first biotech victim of big pharma's current deal-making flurry. It's unlikely to be the last, particularly if Pfizer Inc. succeeds in its bid to land Astrazeneca plc. (See BioWorld Today, April 29, 2014.)

Although €700 million (US$970.6 million) in milestones was attached to the TG4010 program, for Basel, Switzerland-based Novartis it was still pretty small beer when stacked up against the mammoth task of integrating London-based Glaxosmithkline plc's oncology business, for which it has just splashed out $14.5 billion (with another $1.5 billion milestone on the table) as part of a wider reshuffling of assets. That deal also gives Novartis opt-in rights on GSK's oncology pipeline. (See BioWorld Today, April 23, 2014.)

Transgene is now faced with the task of finding a new partner for the program, a challenge that does not unduly phase CEO Philippe Archinard. "There's no reason to be overly anxious. It's just more work, more uncertainty," he told BioWorld Today.

He is confident that the company will land a new deal by late 2014, by which time the first glimpse of overall survival data from the phase IIb study should be available. "The maturation of the data are very, very comforting," he said. "I'm not worried at all as regards the quality of the data."

Further big pharma consolidation could limit the number of takers for the project. "It may statistically reduce the number of partners if everything goes through," he said. It is in a field that is buzzing with deals, however. "At the end of the day there is sufficient appetite for immunotherapy in oncology."

Transgene wants to move TG4010 directly into the phase III portion of the current study later this year. It is planning to follow the same protocol as that of the phase IIb study, which is comparing the safety and efficacy of the vaccine to placebo in MUC1-positive NSCLC patients.

TG4010 failed to hit the primary endpoint of progression-free survival in the phase IIb leg of the study, although the company has attributed this to the use of a predictive biomarker that set a high threshold for efficacy and which will not be used in the same way in the phase III study.

At this point, some companies are combining therapeutic vaccines with other agents, particularly immune checkpoint inhibitors, in the hope of seeing enhanced efficacy signals. Transgene has no early stage data for such a combination, however, and therefore aims to move immediately on the monotherapy trial, while leaving open the possibility for pursuing a combination at a later date. It has previously studied TG4010, which comprises a modified vaccinia Ankara (MVA) vector encoding the MUC1 antigen and the pro-inflammatory cytokine interleukin 2 (IL-2), in combination with chemotherapy.

Shares in Transgene (PARIS:TGN) closed Tuesday at €9.29, down €1.67.

SANOFI'S MOTIVES ARE UNCLEAR

Meanwhile, Oxford Biomedica plc also fell victim to big pharma's predilection for pipeline prioritization. Paris-based Sanofi Group is handing back rights to its gene therapy program for wet age-related macular degeneration (AMD), Retinostat, which is currently undergoing a phase I trial.

The reasons behind Sanofi's decision – and, indeed, its timing – are not fully clear. Retinostat has just completed dosing in a Phase I trial, but data will not be available until later this year. Sanofi's decision to exit at this point is curious.

"They have obligations elsewhere in their pipeline, which has meant that they cannot continue working with Retinostat," a spokeswoman for Oxford, UK-based Oxford Biomedica told BioWorld Today. "It has nothing to do with the asset."

Through its acquisition of Genzyme Corp., Sanofi gained another clinical stage AMD gene therapy program, involving adeno-associated virus-mediated delivery of a gene encoding a fusion protein, sFLT01, which binds vascular endothelial growth factor.

>In February, Sanofi also opted out of Oxford's Encorstat gene therapy program for preventing corneal graft rejection. It carries the same genetic payload as Retinostat, the genes encoding the anti-angiogenic proteins endostatin and angiostatin. Sanofi is still in place as partner on two other Oxford Biomedica programs, Stargen, in development for Stargadt's disease, and Ushstat, in development for Usher Syndrome type 1b, both of which are in phase I/IIa trials.

Shares in Oxford Biomedica (LONDON:OXB) dropped 2 percent to 2.15 pence.